Essential Tips for Bulletproof cGMP Quality Agreements

Essential Tips for Bulletproof cGMP Quality Agreements

May 3rd, 2013 // 2:36 am @

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Our webinar on quality agreements on May 1 was packed with really interesting tips on how to make sure your quality agreement is in fully cGMP compliance so you never get an FDA 483. The speaker, Alan Minsk, a partner for Arnall, Gold and Gregory in Atlanta, pointed out the following:

  • Overall, quality agreements usually pertain to cGMPs and drugs. However, Alan’s team is starting to get more questions on GCPs and clinical trials. He recommended that you have quality agreements with many of your suppliers in a clinical setting.
  • He noted that for both GCPs and GMPs, there is not quality agreement requirement per se. But if you do not have quality agreements set up with your key suppliers, you are setting yourself up for potential FDA compliance problems. Remember, as the sponsor, YOU are on the hook if anything goes wrong with the supplier.
  • Alan mentioned a client medical device company that relied on a 3rd party vendor to be compliant with GMPs. The sponsor ended up getting both an import alert AND an FDA 483. You need to be sure that your 3rd party vendors have quality agreements that have been signed. Equally important is to make sure that the agreement is being followed.
  • Drug contract deals can go through so fast that no one really checks with the quality people to see if everything in the contract is really doable. Are the time frames reasonable? Sometimes the quality people are the last ones to find out about a deal and they haven’t been consulted on the fine print on the quality side.
  • The sponsor’s management also needs to know what is in the quality agreement and that everything is possible for quality to handle.
  • Alan stressed the need to not make up definitions on the fly in the quality agreement. If FDA has a definition, say, adverse event or recall, you need to use that definition, because during an inspection, that is what you are going to be held to.
  • It is key to define time limits for investigations. ‘As soon as possible’ does not do it. You need to state 24 hours or 48 hours in the quality agreement.
  • Regarding having agreements with all vendors, Alan says you have to determine how important that relationship is to the safety and efficacy of the product. If it is an API or a device component, yes, you probably want a quality agreement.
  • You should have it stated in your cGMP quality agreement if a 3rd party is going to be inspected. If the inspection involves your product, you should have it in the quality contract that your firm will be part of the FDA response.

Overall, it was a highly informative webinar on quality agreements. We are rerunning this event later in May, so check it out.

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